(198 days)
PowerLoc™ Max Power Injectable Infusion Set:
The PowerLoc™ Max Power Injectable Infusion Set is a device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through surgically implanted vasular ports. When used with ports that are indicated for power injection of contrast media into the central venous system, the PowerLoc™ Max Power Injectable Infusion Set is also indicated for power injection of contrast media. These devices may be used in any patient population with an implanted vascular port.
For power injection of contrast media, the maximum recommended infusion rate at 11.8 cPs is 5 mL/s for 19 gauge and 20 gauge needles, and 2 mL/s for 22 gauge needles.
SafeStep™ Huber Needle Set:
The SafeStep™ Huber Needle Set is a device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through surgically implanted vascular ports.
These devices may be used in any patient population with an implanted vascular port.
Note: The SafeStep™ Huber Needle Set is NOT indicated for power injection of contrast media or any other high pressure injection.
PowerLoc™ Max Power Injectable Infusion set is a non-coring Huber needle and infusion set with a manually activated needlestick prevention safety mechanism. These devices access surgically implanted subcutaneous vascular ports by penetrating the port septum to provide a closed fluid pathway for the infusion of fluids and drugs, as well as blood sampling. In addition, it may be used for power injection of contrast media through an implanted vascular port that is also indicated for power injection up to 325 psi (2241 kPa). It is supplied sterile and non-pyrogenic, for single use only.
The PowerLoc™ Max Power Injectable Infusion Set is offered with and without a Y-site.
SafeStep™ Huber Needle Set:
The SafeStep™ Huber Needle Set is a device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through surgically implanted vascular ports.
These devices may be used in any patient population with an implanted vascular port.
Note: The SafeStep™ Huber Needle Set is NOT indicated for power injection of contrast media or any other high pressure injection.
This document describes the premarket notification for the "PowerLoc™ Max Power Injectable Infusion Set" and "SafeStep™ Huber Needle Set". The study presented focuses on demonstrating substantial equivalence to a predicate device (K171735) through performance testing, rather than a standalone clinical study to establish new acceptance criteria. Therefore, much of the requested information regarding clinical studies, expert-established ground truth, and training data is not applicable in this context.
Here's a breakdown of the available and applicable information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for each test are implied by the "All testing passed the predetermined acceptance criteria" statement. Specific quantitative acceptance criteria or detailed performance results are not provided in this summary. Instead, the document lists the type of test conducted and the standard it references, indicating compliance.
| Test Category | Reference Standard / Test Description | Device Performance (as reported) |
|---|---|---|
| Biocompatibility | ISO 10993-1:2009 – Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process. Tests include Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogenicity, Subchronic Systemic Toxicity, Hemocompatibility. | Passed, free from biological hazard, material acceptability confirmed by health-based risk assessment. |
| Assembly Burst | ISO 10555-1:2013 – Sterile Single-Use Intravascular Catheters – Part 1: General requirements. Test to confirm assembly burst pressure exceeds peak pressure at maximum flow conditions. | Passed (exceeded peak pressure). |
| Assembly Tensile | ISO 8536-4:2019 – Infusion equipment for medical use – Part 4: Infusion sets for single use, gravity feed. Test to demonstrate peak tensile force of each assembly exceeds minimum peak tensile force. | Passed (exceeded minimum peak tensile force). |
| Assembly Air Leak | ISO 8536-10:2015 – Infusion equipment for medical use – Part 10: Accessories for fluid lines for single use with pressure infusion equipment. Test to confirm no leak when occluded. | Passed (no leak). |
| Assembly High Pressure Water Leak/Burst (2X) | ISO 8536-10:2015 – Infusion equipment for medical use – Part 10: Accessories for fluid lines for single use with pressure infusion equipment. Test to confirm PowerLoc™ Max does not leak or burst at maximum indicated flow rate. | Passed (no leak or burst at max indicated flow rate). |
| Assembly Occlusion/Flow Rate | ISO 7864:2016: Sterile hypodermic needles for single use – Requirements and test methods. Test to confirm minimum flow rates. | Passed (confirmed minimum flow rates). |
| Clamp Function | Internal Standard. Test to confirm fluids will not pass through tubing when the clamp is engaged. | Passed (no fluid passage when clamp engaged). |
| Luer Adapter Testing | ISO 80369-7: Small-bore connectors for liquids and gases in healthcare applications – Part 7: Connectors for intravascular or hypodermic applications. Tests include Leak, Leak Decay, Stress Cracking, Resistance to Separation from Axial Load, Unscrewing, Overriding. | Passed (met all requirements). |
| Particulate Testing | USP <788>: Sizing and Counting Particulate Matter. Test to ensure particulate matter on the catheter post-manufacture is not exceeded for prescribed particle sizes. | Passed (particulate matter levels not exceeded). |
| Needleless Y-Site Testing | Guidance for Industry and FDA Staff: Intravascular Administration Sets Premarket Notification Submissions [510(k)] (2008). Tests include Microbial Ingress, Valve Activation, Air Introduction Due to Device Connect/Disconnect. | Passed (met all requirements for SafeStep™ Huber Needle Set configurations with Y-site). |
| Residual Toxicity (Ethylene Oxide Residuals) | ISO 10993-7:2008: Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals. Test to ensure EO residuals are below requirements for any patient with an implanted port. | Passed (EO residuals below required levels). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes used for each individual performance test. It broadly states "All testing passed the predetermined acceptance criteria."
- Data Provenance: The studies were conducted "by or for Bard Access Systems (BD)". The data is presumably from laboratory testing, not patient data (retrospective or prospective), given the nature of the device and the tests performed. The country of origin for the data is not specified, but the applicant's address is in Salt Lake City, Utah, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable. The device's substantial equivalence was established through engineering and performance testing against recognized standards, not through clinical trials requiring expert-established ground truth on patient data.
4. Adjudication Method for the Test Set
This information is not applicable, as no clinical study with human observers or adjudication committees was performed.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If So, What was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance
This is not applicable. This is a medical device (infusion set and Huber needle set), not an AI-powered diagnostic or assistive tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
This is not applicable. This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance tests would be the established requirements and limits defined by the referenced ISO standards, USP standards, and internal protocols for a device of this type. For example, for "Assembly Burst," the ground truth is that the device must withstand a certain pressure without bursting, as defined by ISO 10555-1.
8. The Sample Size for the Training Set
This is not applicable. There is no AI component or training set involved in the assessment of this physical medical device.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set. The "ground truth" for the device's acceptable performance is derived from established international and national standards for medical devices and internal quality control protocols.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 27, 2024
Bard Access Systems, Inc. Catherine Langford Regulatory Affairs Specialist 605 North 5600 West Salt Lake City, Utah 84116
Re: K241353
Trade/Device Name: PowerLoc™ Max Power Injectable Infusion Set: SafeStep™ Huber Needle Set Regulation Number: 21 CFR 880.5570 Regulation Name: Hypodermic Single Lumen Needle Regulatory Class: Class II Product Code: PTI Dated: October 28, 2024 Received: October 28, 2024
Dear Catherine Langford:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory
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assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Porsche Bennett
Porsche Bennett for David Wolloscheck, Ph.D. Assistant Director DHT3C: Division of Drug Delivery and General Hospital Devices, and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K241353
Device Name
PowerLoc™ Max Power Injectable Infusion Set; SafeStep™ Huber Needle Set
Indications for Use (Describe)
PowerLocTM Max Power Injectable Infusion Set:
The PowerLoc™ Max Power Injectable Infusion Set is a device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through surgically implanted vasular ports. When used with ports that are indicated for power injection of contrast media into the central venous system, the PowerLoc™ Max Power Injectable Infusion Set is also indicated for power injection of contrast media. These devices may be used in any patient population with an implanted vascular port.
For power injection of contrast media, the maximum recommended infusion rate at 11.8 cPs is 5 mL/s for 19 gauge and 20 gauge needles, and 2 mL/s for 22 gauge needles.
SafeStep™ Huber Needle Set:
The SafeStep™ Huber Needle Set is a device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through surgically implanted vascular ports.
These devices may be used in any patient population with an implanted vascular port.
Note: The SafeStep™ Huber Needle Set is NOT indicated for power injection of contrast media or any other high pressure injection.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | |
| £ Over-The-Counter Use (21 CFR 801 Subpart C) |
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| ContactDetails21 CFR807.92(a)(1) | Submitter Name: | Bard Access Systems, Inc. |
|---|---|---|
| Submitter Address: | 605 North 5600 WestSalt Lake City, Utah 84116 USA | |
| Contact Telephone: | 801.522.5000 | |
| Contact Person: | Catherine LangfordRegulatory Affairs Specialist | |
| Contact Email | catherine.langford@bd.com | |
| Date of Preparation: | 27 November 2024 | |
| Device Name21 CFR807.92(a)(2) | Trade Name: | PowerLoc™ Max Power Injectable Infusion Set;SafeStep™ Huber Needle Set |
| Common Name: | Hypodermic single lumen needle | |
| Classification Name: | Non-Coring (Huber) Needle | |
| Class: | Class II | |
| Regulation Number: | 880.5570 | |
| Product Code: | PTI | |
| Classification Panel: | General Hospital | |
| PredicateDevice21 CFR807.92(a)(3) | Trade Name: | PowerLoc® MAX Power-Injectable Infusion Set;SafeStep® Huber Needle Set |
| Common Name | Hypodermic single lumen needle | |
| Classification Name: | Non-Coring (Huber) Needle | |
| Class: | Class II | |
| Regulation Number: | 880.5570 | |
| Product Code: | PTI | |
| Premarket NotificationNumber: | K171735 |
K241353 - 510(k) Summary 21 CFR 807.92(a)
PowerLoc™ Max Power Injectable Infusion Set:
The PowerLoc™ Max Power Injectable Infusion Set is a device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through surgically implanted vascular ports. When used with ports that are indicated for power injection of contrast media into the central venous system, the PowerLoc™ Max Power Injectable Infusion Set is also indicated for power injection of contrast media. These devices may be used in any patient population with an implanted vascular port.
Indications for Use 21 CFR 807.92(a)(5)
For power injection of contrast media, the maximum recommended infusion rate at 11.8 cPs is 5 mL/s for 19 gauge and 20 gauge needles, and 2 mL/s for 22 gauge needles.
SafeStep™ Huber Needle Set:
The SafeStep™ Huber Needle Set is a device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through surgically implanted vascular ports.
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These devices may be used in any patient population with an implanted vascular port.
Note: The SafeStep™ Huber Needle Set is NOT indicated for power injection of contrast media or any other high pressure injection.
| DeviceDescription21 CFR807.92(a)(4) | PowerLoc™ Max Power Injectable Infusion SetPowerLoc™ Max Power Injectable Infusion set is a non-coring Huber needle and infusion set with a manually activated needlestick prevention safety mechanism. These devices access surgically implanted subcutaneous vascular ports by penetrating the port septum to provide a closed fluid pathway for the infusion of fluids and drugs, as well as blood sampling. In addition, it may be used for power injection of contrast media through an implanted vascular port that is also indicated for power injection up to 325 psi (2241 kPa). It is supplied sterile and non- pyrogenic, for single use only.The PowerLoc™ Max Power Injectable Infusion Set is offered with and without a Y-site.SafeStep™ Huber Needle SetThe SafeStep™ Huber Needle Set is a device intended for insertion into the septum of a subcutaneously implanted port for the infusion of fluids and drugs, as well as blood sampling through surgically implanted vascular ports.These devices may be used in any patient population with an implanted vascular port.Note: The SafeStep™ Huber Needle Set is NOT indicated for power injection of contrast media or any other high pressure injection. |
|---|---|
| ------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
Image /page/5/Picture/4 description: The image shows a diagram of the Subject PowerLoc Max Power Injectable Infusion Set (19 GA with Y-site shown). The diagram includes labels for the different parts of the infusion set, such as the female locking luer connection, safety guard handle, administration tubing, adaptable Y-site female locking luer connection, Huber needle, pinch clamps, and non-vented male luer caps. The safety guard base includes the inner base, sleeve, shutter, and comfort pad.
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Image /page/6/Figure/1 description: The image shows a SafeStep Huber Needle Set (19 GA with needleless Y-site shown). The different parts of the needle set are labeled, including the needleless access connector Y-site, pinch clamps, administration tubing, female locking luer connection, Huber needle, safety guard base, non-vented male luer cap, and safety guard handle. The image also includes text describing the indications for use and comparison of the Huber Needle Set. The text states that the intended use has not changed compared to the predicate.
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| Component | SUBJECT DEVICEPowerLoc™ Max PowerInjectable Infusion SetSafeStep™ Huber Needle Set | PREDICATE DEVICE (K171735)PowerLoc™ Max PowerInjectable Infusion SetSafeStep™ Huber Needle Set | |
|---|---|---|---|
| Huber Needle | Same as predicate | Stainless Steel | |
| Adhesive | Same as predicate | UV Cured Acrylic | |
| Needle Lubricant | Silicone | Silicone | |
| Needle Cover | Same as predicate | Polyethylene | |
| Safety Guard Base | Same as predicate | Styrene-Butadiene Copolymer orPolycarbonate | |
| Safety GuardInner Based | Same as predicate | Styrene-Butadiene Copolymer +Colorant19GA (Yellow)20GA (Brown)22GA (Black) | |
| Safety GuardSleeve | Same as predicate | Stainless steel | |
| Safety GuardShutter | Same as predicate | Stainless steel | |
| Safety GuardHandle | Same as predicate | Styrene-Butadiene Copolymer | |
| Safety GuardComfort Pad | Same as predicate | Polyethylene | |
| AdministrationTubing | Thermoplastic polyurethane | Polyvinyl chloride | |
| Female LockingLuer Connection | Polyvinyl chloride (Type of PVC anddimension) | Polyvinyl chloride | |
| Adaptable Y-Injection siteFemale LockingLuer Connection | Same as predicate | Polyvinyl chloride | |
| Non-vented MaleLuer Cap | Same as predicate | Acrylonitrile butadiene styrene +White Colorant | |
| Pinch Clamp | Acetal (polyoxymethylene) +Colorant19G: Brown20G: Yellow22G: Black | Polypropylene + Colorant19G: Brown20G: Yellow22G: Black | |
| Pinch Clamp Ink(PowerLoc™ MaxPower InjectableInfusion SetONLY) | White InkBlack Ink | White InkBlack Ink | |
| Needless AccessConnector Y-Site | Same as predicate | Polycarbonate |
Technological
Comparisonison
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.
| (SafeStep™ HuberNeedle Set ONLY) | ||
|---|---|---|
| Needless AccessConnector Y-SiteValve (SafeStep™Huber Needle SetONLY) | Same as predicate | Silicone |
| FundamentalScientificTechnology | Same as predicate | The device accesses implantedports to transport fluid into andout of the central venous system.It utilizes a standard right anglenon-coring Huber needle andadministration set with aneedlestick prevention feature. |
| Device Sizesand TubingDimensions | Same as predicate | Needle Gauge - 19G, 20G or 22GNeedle Length - 0.75 in., 1.00 in.,1.50 in.Clamp Color Guided by ISO 6009 -19G Brown, 20G Yellow,22G BlackTubing dimension with needlelessY-site - 4.00 inTubing dimension withoutneedleless Y-site - 8.00 in |
| ProductConfigurations | Same as predicate | Standalone and convenience kit |
| SterilizationModality | Ethylene Oxide | Ethylene Oxide |
| Minimum SAL | Same as predicate | 1 x 10-6 |
| Anatomical SiteUse | Same as predicate | The site of a surgically implantedvascular port. |
| Disposable orReusable | Same as predicate | Disposable - Single-use device |
| Safety InfusionSet DeviceComponents | End CapLuer ConnectorTubingNon-Winged GripSafety Guard BasePinch ClampsNeedleNeedle Handle | End CapLuer ConnectorTubingNon-Winged GripSafety Guard BasePinch ClampsNeedleNeedle Handle |
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| Subject DevicePowerLoc™ Max Power InjectableInfusion Set | Predicate Device (K171735)PowerLoc™ Max Power InjectableInfusion Set | |
|---|---|---|
| Gauge(G) | Power Injector Flow Rate at 11.8 cPsat 325 psi (2241 kPa) | Power Injector Flow Rate at 11.8 cPsat 325 psi (2241 kPa) |
| 19 | Same as predicate | 5 mL/s |
| 20 | Same as predicate | 5 mL/s |
| 22 | Same as predicate | 2 mL/s |
| Subject DevicePowerLoc™ MaxPower InjectableInfusion SetSafeStep™ HuberNeedle Set | Predicate Device (K171735)PowerLoc™ Max Power Injectable Infusion SetSafeStep™ Huber Needle Set | ||
|---|---|---|---|
| PrimingVolume (onlabeling) | Same as predicate | Without Y-site | 0.3 mL |
| SafeStep™ withneedleless Y-site | 0.7 mL | ||
| PowerLoc™ Max withY-site | 0.4 mL | ||
| ResidualVolume | Same as predicate | SafeStep™ withneedleless Y-site | <.35 mL |
| ConnectorTypes | Same as predicate | Without Y-site | 1 Female Luer lockadapter |
| SafeStep™ withneedleless Y-site | 1 Female Luer lockadapter1 Needleless Y-siteconnector | ||
| PowerLoc™ Max withY-site | 1 Female Luer lock1 Y-site Luer lockconnector |
Comment 1: The material formulation for the administration tubing and pinch clamps have changed to those currently used in a similarly marketed device (K060812) with the same biological contact and duration. Biocompatibility and performance testing were conducted to demonstrate the differences do not raise new or different questions of safety and effectiveness.
Comment 2: The type of PVC material was changed for the female Luer locking connection and there were dimensional changes to the female Luer locking connection to comply with ISO80369-7. Biocompatibility and performance testing; respectively were conducted to demonstrate the differences do not raise new or different questions of safety and effectiveness.
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In summary, the subject and predicate devices utilize the same fundamental scientific technologies. The subject device is substantially equivalent to the predicate device with respect to components, component materials, and dimensions. In addition, the BD-owned subject and predicate devices were designed in compliance with the same consensus standards.
The following performance tests were conducted by or for Bard Access Systems (BD) per guidance documents and standards in conjunction with in-house protocols to establish the performance of the PowerLoc™ Max Power Injectable Infusion Set and SafeStep™ Huber Needle Set, and in determining substantial equivalence to the predicate K171735. All testing passed the predetermined acceptance criteria.
| Safety &PerformanceTests21 CFR807.92(b) | Reference Standard: ISO 10993-1:2009 – Biological Evaluation of Medical Devices – Part 1:Evaluation and testing within a risk management process | |
|---|---|---|
| Tests to confirm that the catheter is free from biological hazard per testing. Ahealth-based risk assessment per ISO 10993-1 was performed for determiningthe acceptability of the material for the intended purpose. | ||
| BiocompatibilityTesting | Testing Performed includes:Cytotoxicity Sensitization Irritation or Intracutaneous Reactivity Acute Systemic Toxicity Pyrogenicity Subchronic Systemic Toxicity Hemocompatibility | |
| Reference Standard: ISO 10555-1:2013 – Sterile Single-Use Intravascular Catheters – Part 1:General requirements | ||
| Assembly Burst | Burst pressure test to confirm the assembly burst pressure exceeds the peakpressure at maximum flow conditions. | |
| Reference Standard: ISO 8536-4:2019 – Infusion equipment for medical use – Part 4: Infusion setsfor single use, gravity feed | ||
| AssemblyTensile | Test to demonstrate the peak tensile force of each assembly exceeds theminimum peak tensile force. | |
| Reference Standard: ISO 8536-10:2015 – Infusion equipment for medical use – Part 10:Accessories for fluid lines for single use with pressure infusion equipment | ||
| Assembly AirLeak | Test to confirm that the assembly will not leak when occluded. | |
| Assembly HighPressure WaterLeak/Burst (2X) | Test to confirm the PowerLoc™ Max Power Injectable Infusion Set does notleak or burst at maximum indicated flow rate. | |
| Reference Standard: ISO 7864:2016: Sterile hypodermic needles for single use – Requirementsand test methods | ||
| AssemblyOcclusion/FlowRate | Test to confirm minimum flow rates. | |
| Internal Standard | ||
| Clamp Function | Test to confirm that fluids will not pass through tubing when the clamp is engaged. | |
| Reference Standard: ISO 80369-7: Small-bore connectors for liquids and gases in healthcareapplications – Part 7: Connectors for intravascular or hypodermic applications | ||
| Luer AdapterTesting | Testing to ensure that Luer adapters meet requirements for:• Leak• Leak Decay• Stress Cracking• Resistance to Separation from Axial Load• Resistance to Separation from Unscrewing• Resistance to Overriding | |
| Reference Standard: USP<788>: Sizing and Counting Particulate Matter | ||
| ParticulateTesting | Testing to ensure that particulate matter on the catheter post-manufacture is not exceeded for prescribed particle sizes. | |
| Reference Standard: Guidance for Industry and FDA Staff: Intravascular Administration SetsPremarket Notification Submissions [510(k)] (Document Issued July 11, 2008) | ||
| Needleless Y-Site Testing | Testing to ensure needleless access connector used in SafeStep™ HuberNeedle Set configurations with Y-site meet requirements for:• Microbial Ingress• Valve Activation• Air Introduction Due to Device Connect/Disconnect | |
| Reference Standard: ISO 10993-7:2008: Biological evaluation of medical devices - Part 7: Ethyleneoxide sterilization residuals [Including: Technical Corrigendum 1 (2009), AMENDMENT 1:Applicability of allowable limits for neonates and infants (2019)] | ||
| Residual Toxicity | Testing to ensure EO residuals are below requirements for any patient with an implanted port. | |
| Clinical Testing | Clinical data was not needed to demonstrate substantial equivalence. | |
| TechnologicalComparison toPredicateDevice | The subject PowerLoc™ Max Power Injectable Infusion Set and SafeStep™ HuberNeedle Set has the same intended use and fundamental technological characteristicsas the cited predicate device cleared under K171735. The tubing and clampmaterials differ from the predicate device; however, this difference does not alter theintended use of the subject device and does not raise any new or different questionsregarding safety or effectiveness when compared to the predicate device. | |
| Summary ofSubstantialEquivalence | Based on the intended use, technological characteristics, and results of performancetesting, the subject PowerLoc™ Max Power Injectable Infusion Set and SafeStep™Huber Needle Set is considered substantially equivalent to the cited predicate device. |
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§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).